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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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The Bebe Vie is a single-use pediatric laryngoscope for intubation of toddlers to age ten.
ADROIT SURGICAL
BB-111
In Commercial Distribution

  • 00860115000612 ()
  • 00860115000681 ()


  • Rigid intubation laryngoscope, single-use
MATERIAL ADDED TO SYSTEM FOR TEST - NOT A HARRIS BRANDED MEDICAL REGULATOR, NO DI REQUIREMENT
J. W. HARRIS CO., INC.
Regulator REG,3500-125-540
In Commercial Distribution

  • 00850005066002 ()
3003500

  • Medical air cylinder regulator
Salmonella O Polyvalent A-I Kit Group: A, B, C, D, E, F, G, H, I
PRO-LAB, INCORPORATED
PLA003
In Commercial Distribution

  • 00817978020004 ()


  • Multiple Salmonella species culture isolate antigen IVD, reagent
The PhotonGuide is intended to provide surgical site illumination from a high intensity light source.
INVUITY, INC.
Wide / Angled
In Commercial Distribution

  • 00816728020066 ()

  • Angle: Angled
  • Width: Wide
102521

  • Surgical instrument fibreoptic light
The PhotonGuide is intended to provide surgical site illumination from a high intensity light source.
INVUITY, INC.
Wide / Angled
In Commercial Distribution


  • Width: Wide
  • Angle: Angled
102521

  • Surgical instrument fibreoptic light
The PhotonGuide is intended to provide surgical site illumination from a high intensity light source.
INVUITY, INC.
Narrow / Angled
In Commercial Distribution

  • 00816728020097 ()

  • Angle: Angled
  • Width: Narrow
104001

  • Surgical instrument fibreoptic light
Applied as an intermediate between enamel or dentin and as a restorative material or cement.
SCIENTIFIC PHARMACEUTICALS, INC.
SP 60-024
In Commercial Distribution

  • D801SP600241 ()
60-024

  • Dentine adhesive
Rowen Phaco Spatula a Combination of the Rosen Phaco Splitter and the Bechert Nucleus Rotator
Surgical Direct, Inc.
SD934490102
In Commercial Distribution

  • B382SD9344901020 ()
SD934490102

  • Ocular hook/spatula/manipulator, reusable
The ROTEM® delta is designed for in-vitro diagnostic use by professionals in a laboratory environment. The ROTEM® delta is intended to be used to provide a qualitative and quantitative indication of the coagulation state of a blood sample. For this purpose the ROTEM® delta records the clot firmness changes in a sample of citrated whole blood as the sample clots, retracts and lyses in real time. The analyzer output consists of a qualitative graphical representation (mirrored coagulation curve - clot firmness over time) and several defined numerical parameters describing the curve quantitatively.
Tem Innovations GmbH
delta System (US/CA)
In Commercial Distribution

  • 04260160470587 ()
201001

  • Coagulation analyser IVD, laboratory, semi-automated
The ROTEM® delta is designed for in-vitro diagnostic use by professionals in a laboratory environment. The ROTEM® delta is intended to be used to provide a qualitative and quantitative indication of the coagulation state of a blood sample. For this purpose the ROTEM® delta records the clot firmness changes in a sample of citrated whole blood as the sample clots, retracts and lyses in real time. The analyzer output consists of a qualitative graphical representation (mirrored coagulation curve - clot firmness over time) and several defined numerical parameters describing the curve quantitatively.
Tem Innovations GmbH
delta System
In Commercial Distribution

  • 04260160470020 ()
200100-US

  • Coagulation analyser IVD, laboratory, semi-automated
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